Details for New Drug Application (NDA): 209862
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The generic ingredient in EVZIO (AUTOINJECTOR) is naloxone hydrochloride. There are twelve drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride profile page.
Summary for 209862
Tradename: | EVZIO (AUTOINJECTOR) |
Applicant: | Kaleo Inc |
Ingredient: | naloxone hydrochloride |
Patents: | 33 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209862
Mechanism of Action | Opioid Antagonists |
Medical Subject Heading (MeSH) Categories for 209862
Suppliers and Packaging for NDA: 209862
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
EVZIO (AUTOINJECTOR) | naloxone hydrochloride | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | 209862 | NDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1495 | 51662-1495-1 | 2 DOSE PACK in 1 CARTON (51662-1495-1) / .4 mL in 1 DOSE PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS | Strength | 2MG/0.4ML (2MG/0.4ML) | ||||
Approval Date: | Oct 19, 2016 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Try a Trial | Patent Expiration: | May 24, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | USE OF A DELIVERY DEVICE TO DELIVER A DOSE OF NALOXONE | ||||||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 20, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | USE OF A DELIVERY DEVICE TO DELIVER A BIOEQUIVALENT DOSE OF A NALOXONE COMPOSITION VIA A NEEDLE | ||||||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Nov 23, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? |
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